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ABC Trial: Awakening and Breathing Controlled

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ClinicalTrials.gov Identifier: NCT00097630
Recruitment Status : Completed
First Posted : November 25, 2004
Last Update Posted : December 11, 2009
St. Thomas Foundation, Tennessee
Vanderbilt University
Information provided by:
National Institute on Aging (NIA)

Brief Summary:
The purpose of this study is to determine the impact of a new RN/RRT (Registered Nurse/Registered Respiratory Therapist) directed 2-step protocol to wean patients off of a ventilator. This protocol involves daily attempts to halt sedation (spontaneous awakening trials) combined with daily assessments of patients while they are breathing on their own (spontaneous breathing trials).

Condition or disease Intervention/treatment Phase
Aging Respiration, Artificial Procedure: SAT: Spontaneous Awakening Trial Procedure: SBT: Spontaneous Breathing Trial Not Applicable

Detailed Description:

Unnecessary delays in removing patients from mechanical ventilation increase morbidity, mortality, and cost. According to recently published guidelines, the current standard of care for weaning involves the daily assessment of patients while they are breathing spontaneously, also known as spontaneous breathing trials (SBT). While there are important data to support a daily cessation of sedatives and analgesics to the point of patient awakening, the benefit of combining such a daily spontaneous awakening trial (SAT) and an SBT is not known.

This multi-center, randomized controlled trial will test whether a 2-step process of weaning that combines a daily awakening trial (achieved by stopping all sedatives and narcotics every morning) with a daily spontaneous breathing trial is superior to the current standard of care.

The number of days the patient is able to live off the ventilator is the primary question being studied. The secondary questions include the number of days the patient is in Intensive Care Unit (ICU) and the hospital, the complications associated with being on the ventilator (such as the duration and severity of delirium and coma), and in-hospital and one-year mortality. Also, cognitive, psychological, and functional/quality of life outcomes will be measured at discharge and 3 and 12 months later.

In addition, the study will measure plasma drug levels twice daily on five sequential days within 30 minutes of testing with highly reliable and well validated instruments to measure sedation level (i.e., RASS) and delirium (i.e. CAM-ICU).

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Study Type : Interventional  (Clinical Trial)
Enrollment : 334 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Cognitive Impairment in the ICU: Evaluation and Outcomes
Study Start Date : October 2003
Actual Primary Completion Date : August 2007
Actual Study Completion Date : August 2007

Primary Outcome Measures :
  1. Ventilator free days

Secondary Outcome Measures :
  1. Length of stay in the ICU and hospital
  2. 28-day and 1-year survival
  3. Duration of coma and delirium
  4. Cognitive function [ Time Frame: at discharge, 3 months, and 12 months ]
  5. Psychological status [ Time Frame: at discharge, 3 months, and 12 months ]
  6. Functional status [ Time Frame: at discharge, 3 months, and 12 months ]
  7. Quality of life [ Time Frame: at discharge, 3 months, and 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Recently on mechanical ventilation (less than 2 weeks prior to enrollment)
  • Require mechanical ventilation for more than 12 hours
  • Over 18 years old
  • Under the services of medicine, cardiology, and neurology

Exclusion Criteria:

  • Admission after cardiopulmonary arrest
  • Inability to obtain informed consent
  • Existence of an extubation order at the time of the evaluation
  • Dependence upon mechanical ventilation for 2 weeks prior to enrollment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00097630

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United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
University of Pennsylvania - Presbyterian Medical Center
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
St. Thomas Hospital
Nashville, Tennessee, United States, 37202
Sponsors and Collaborators
National Institute on Aging (NIA)
St. Thomas Foundation, Tennessee
Vanderbilt University
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Principal Investigator: E Wesley Ely, MD, MPH Vanderbilt University Medical Center
Study Director: Brenda T Pun, RN, ACNP Vanderbilt University Medical Center
Principal Investigator: Richard W Light, MD St. Thomas Hospital
Additional Information:
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00097630    
Other Study ID Numbers: AG0011
5K23AG001023-04 ( U.S. NIH Grant/Contract )
First Posted: November 25, 2004    Key Record Dates
Last Update Posted: December 11, 2009
Last Verified: August 2008
Keywords provided by National Institute on Aging (NIA):
mechanical ventilation
sedation scoring
cognitive impairment
ventilation weaning